Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

NCT ID: NCT05717127

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-06-01

Brief Summary

One known cause of type 2 diabetes (T2DM) is beta-cell dysfunction, which refers to the inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. Unfortunately, no anti-diabetic medication or lifestyle intervention has been shown to prevent the worsening of beta-cell function over time. Interestingly, however, intermittent fasting (IF) - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with T2DM, it is also been shown to improve glycemic control (i.e. reduce the sugar levels). While no research has studied whether IF can improve pancreatic beta-cell function, the positive metabolic effects suggest that it could provide some benefit. The current study will evaluate whether IF can improve pancreatic beta-cell function in individuals with early T2DM.

Conditions

Diabetes Mellitus, Type 2; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intermittent fasting (time restricted feeding)

Intermittent fasting (IF) study arm consisting of time restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM).

Group Type: EXPERIMENTAL

Time restricted feeding

Intervention Type: BEHAVIORAL

Restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM).

Standard lifestyle

Standard lifestyle recommendation as per the Diabetes Canada guidelines, where participants are encouraged to maintain regularity in timing and spacing of means with no specific recommendations regarding the hours of fasting

Group Type: ACTIVE_COMPARATOR

Standard lifestyle

Intervention Type: BEHAVIORAL

Standard lifestyle recommendations

Interventions

Time restricted feeding

Restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM).

Intervention Type: BEHAVIORAL

Standard lifestyle

Standard lifestyle recommendations

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and women with type 2 diabetes mellitus diagnosed within preceding 10 years
• Age 20-70 years inclusive
• Body mass index ≥ 25 kg/m2
• Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination
• HbA1c value of 5.5 - 9.0% inclusive

Exclusion Criteria

• Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter 2 (SGLT-2) and/or sulfonylureas
• Involvements in any other clinical study on lifestyle intervention or requiring drug therapy
• Any history or eating disorder
• Renal dysfunction as evidenced by estimated glomerular filtration rate <45 mL/min by Modification of Diet in Renal Disease (MDRD) formula
• Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5x the upper limit of normal
• Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
• Any other factor likely to limit adherence to the study, in the opinion of the investigators

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Caroline Kramer

Principal investigator, Endocrinologist and Clinician-scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Kramer CK, Zinman B, Feig DS, Retnakaran R. Effect of Time-Restricted Eating on beta-Cell Function in Adults With Type 2 Diabetes. J Clin Endocrinol Metab. 2025 May 19;110(6):e2045-e2053. doi: 10.1210/clinem/dgae594.

Reference Type: BACKGROUND

PMID: 39193706 (View on PubMed)

Other Identifiers

19-0299-A

Identifier Type: -

Identifier Source: org_study_id